(39 days)
Electrosurgical accessory. Monopolar electrosurgical coagulator for controlling bleeding by use of high-frequency electrical current and a suction tube for removal of fluids and debris from the surgical site.
Monopolar Suction Coagulator
This document is a 510(k) clearance letter from the FDA for a Monopolar Suction Coagulator. It does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria related to AI or algorithm performance.
The letter is a regulatory document confirming that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It focuses on regulatory compliance, classification, and general controls, not on detailed performance metrics from a specific study.
Therefore, I cannot extract the requested information from the provided text.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.